Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer
ConditionBreast Cancer Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorMin Yan, MD
About this trial
This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients.
This study was a single-arm, phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes and/or anthracyclines were treated with a combination of utidelone capsules and capecitabine. The main objective was to explore the efficacy and safety of the combined regimen.
Eligibility criteria
Qualifiers
Voluntarily participate in this study, sign an informed consent form, have good compliance, and are willing to follow-up.
Female, aged ≥ 18 and ≤ 70 years, with an ECOG score of 0-1 and an expected survival time of ≥ 12 weeks.
The pathological and/or cytological diagnosis (based on the latest biopsy results) is HER2 negative recurrent or metastatic breast cancer, regardless of hormone receptor status (ER/PR positive or negative, but the hormone receptor status needs to be determined);
All patients have received at least paclitaxel and/or anthracycline as a treatment option;
Disqualifiers
Other malignant tumors within the 5 years prior to enrollment, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, papillary thyroid carcinoma without lymph node metastasis, or squamous cell carcinoma of the skin.
Received systemic anti-tumor therapy within 2 weeks prior to enrollment, including but not limited to endocrine therapy, small molecule targeted therapy, anti-tumor traditional Chinese medicine, etc;
Within the 4 weeks prior to enrollment, chemotherapy, targeted biological therapy or immunotherapy, other clinical investigational drugs, radiation therapy, or major organ surgery (excluding biopsy) or significant trauma have been received, or elective surgery is required during the trial period. Those who have undergone major surgeries;
Received nitroso urea or mitomycin C within 6 weeks prior to enrollment;
Trial design
Treatments tested in this trial
- Utidelone Capsule Plus Capecitabine
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Min Yan, MD
Lead sponsor
Henan Cancer Hospital
Sponsor institution
Beijing Biostar Pharmaceuticals Co., Ltd.
Collaborator
Source ClinicalTrials.gov